MelanomaPhase 1NCT07475572
Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma
A Phase 1 study testing AVT32-DRL_PB and Keytruda in people with Melanoma, run by Alvotech Swiss AG at 1 site in Ukraine.
Trial summary
This is a multicenter, randomized, double-blind, parallel-group, 2 treatment group, repeated dose study to compare the PK, efficacy, safety, and immunogenicity of AVT32-DRL_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in participants with fully resected Stage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- AVT32-DRL_PB and Keytruda
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUkraine
- Study dates
- 10 Aug 2026to 14 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants (male/female) ≥18 years of age at the time of signing the ICF.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.
- Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma
Who cannot join
- Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).
- Has received prior systemic anticancer therapy for melanoma including investigational agents.
- Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed >5 years ago.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants With Stage IIB/C-III Melanoma Following Complete Resection
This is a multicenter, randomized, double-blind, parallel-group, 2 treatment group, repeated dose study to compare the PK, efficacy, safety, and immunogenicity of AVT32-DRL_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in participants with fully resected Stage IIB/C or Stage III melanoma requiring adjuvant treatment with pembrolizumab. Eligible participants will be randomized in a 1:1 ratio to the AVT32-DRL_PB or Keytruda treatment group and stratified by sex (female versus male) and body weight category (≤75 kg versus >75 kg). Study treatments will be administered every 3 weeks (Q3W) as an intravenous (IV) infusion over 30 minutes (1 administration Q3W is 1 treatment cycle). The administered pembrolizumab dose will be 200 mg Q3W for both treatment groups.
- Conditions
- Melanoma
- Being tested
- AVT32-DRL_PB, Keytruda
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVT32-DRL_PBBiological
AVT32-DRL_PB at a dose 200 mg administered intravenously every 3 weeks.
KeytrudaBiological
Keytruda at a dose 200 mg administered intravenously every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AVT32-DRL_PB | Experimental | AVT32-DRL_PB will be administered during double blind period and open label period Receives: Biological: AVT32-DRL_PB |
| Keytruda | Active comparator | Keytruda will be administered during double blind period Receives: Biological: Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
AUC0-3w (Cycle 1)
Measured: Cycle 1 (each cycle is 21 days)
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
AUCtau,ss (Cycle 6)
Measured: Cycle 6 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start10 Aug 2026
- Primary completionOct 2027 (estimated)
- Study completion14 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Reddy's Laboratories Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475572
- Sponsor's protocol ID
- AVT32-DRL-TPK-02
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants With Stage IIB/C-III Melanoma Following Complete Resection
- ClinicalTrials.gov ID
- NCT07475572
- Acronym / sponsor ID
- AVT32-DRL-TPK-02
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Reddy's Laboratories Limited
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- 14 Apr 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, parallel-group, 2 treatment group, repeated dose study to compare the PK, efficacy, safety, and immunogenicity of AVT32-DRL_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in participants with fully resected Stage IIB/C or Stage III melanoma requiring adjuvant treatment with pembrolizumab. Eligible participants will be randomized in a 1:1 ratio to the AVT32-DRL_PB or Keytruda treatment group and stratified by sex (female versus male) and body weight category (≤75 kg versus >75 kg). Study treatments will be administered every 3 weeks (Q3W) as an intravenous (IV) infusion over 30 minutes (1 administration Q3W is 1 treatment cycle). The administered pembrolizumab dose will be 200 mg Q3W for both treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVT32-DRL_PB | Experimental | Biological: AVT32-DRL_PBAVT32-DRL_PB will be administered during double blind period and open label period |
| Keytruda | Active comparator | Biological: KeytrudaKeytruda will be administered during double blind period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants (male/female) ≥18 years of age at the time of signing the ICF.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.
- Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma
Key exclusion criteria (3 listed)
- Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).
- Has received prior systemic anticancer therapy for melanoma including investigational agents.
- Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed >5 years ago.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVT32-DRL_PBAVT32-DRL_PB at a dose 200 mg administered intravenously every 3 weeks. | Biological | AVT32-DRL_PB |
| KeytrudaKeytruda at a dose 200 mg administered intravenously every 3 weeks. | Biological | Keytruda |
Primary outcome
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
Time frame: Cycle 1 (each cycle is 21 days)
AUC0-3w (Cycle 1)
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
Time frame: Cycle 6 (each cycle is 21 days)
AUCtau,ss (Cycle 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVT32-DRL_PB and Keytruda in people with Melanoma, run by Alvotech Swiss AG at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Development Lead (+41 78 659 8989, alvotech.clinical@alvotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab) (time frame: Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.